Cleared Traditional

INTRATEMP SOLUTION WARMER

K083417 · C Change Surgical, LLC · General Hospital

Jan 2009

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K083417 is an FDA 510(k) clearance for the INTRATEMP SOLUTION WARMER, a Warmer, Irrigation Solution (Class I — General Controls, product code LHC), submitted by C Change Surgical, LLC (Winston-Salem, US). The FDA issued a Cleared decision on January 13, 2009, 56 days after receiving the submission on November 18, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 890.5950.

Submission Details

510(k) Number	K083417 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2008
Decision Date	January 13, 2009
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement